Kornimate/medical-research-clean huggingface dataset:
neo-adjuvant peptide receptor mediated radiotherapy with 177lutetium in front of curative intended liver transplantation in patients with hepatic metastasis of neuroendocrine tumors (neo-lebe)

Conditions: Liver; Metastasis; Neuroendocrine Tumors

Summary: the purpose of this study is to show the tumor free long term survival of patients with isolated non-resectable liver metastases of neuroendocrine tumors after neo-adjuvant radio receptor treatment and following liver transplantation.

matching patient will be treated neo-adjuvant at the hospital with 177 lutetium peptide receptor radiotherapy in two following courses. after this treatment it will follow the liver transplantation within 9 month as postmortal or living donor liver transplantation. under certain conditions concerning the evaluation examinations patients can be included in the study. most important factors are no evidence of disease outside the liver, removed primary tumor, patients between 18 and 60 years, no curative surgical resection of the liver metastasis possible.

Eligibility criteria:
inclusion criteria: * age between 18 to 60 years * neuroendocrine tumor with low or intermediate malignant histological appearance * primary tumor removed, no extrahepatic tumor * liver metastasis not resectable * positive evaluation for liver transplantation * primary tumor drained by vena porta * tumor load within the liver \< 50% * stable disease after receptor therapy with 177 lutetium for 6 month exclusion criteria: * prognostic relevant second tumor disease * pregnancy * undifferentiated neuroendocrine carcinoma (who ii, g3) * renal insufficiency \> second degree * progressive carcinoid conditioned heart disease (\>nyha ii) * karnofsky-index \< 60

Keywords: neuroendocrine tumor liver metastasis peptide receptor therapy gastro-entero-pancreatic system
sars-cov-2 variants' effect on pregnancy and long-term outcomes among pregnant women and their newborns in estonia

Conditions: Pregnancy; COVID-19; Post-COVID / Long-COVID; Newborn Health; Miscarriages

Summary: the main aim of the study is to describe the possible impacts of sars-cov-2 and its various genotypes on pregnancy and long-term outcomes among pregnant women and their newborns in estonia.

all the pregnant women in estonia who conceived and gave birth between february 27, 2020, and march 1, 2023 were included in the study. pregnant women will be divided into 2 groups: 1. pregnant women who were diagnosed with covid-19 during the study period, along with their newborns; 2. control group: pregnant women who did not have covid-19 during pregnancy, along with their newborns. the following data is collected for each subject: prior vaccination, previous covid-19 infection, underlying diseases/conditions, hospitalization, need for intensive care, need for mechanical ventilation and/or oxygen therapy, death cases, post-covid-19 symptoms, pregnancy course and outcomes, possible virus transmission from mother to child, and the newborn's condition or accompanying health issues

Eligibility criteria:
inclusion criteria: * pregnancy (conceived and gave birth between february 27, 2020, and march 1, 2023) with covid-19 or without and their newborns exclusion criteria: * na
study of a neuroprotective drug to limit the extent of damage from an ischemic stroke

Conditions: Stroke, Acute

Summary: the primary aim of this study is to find out which of 4 different doses of minocycline are safe and well tolerated so that we will know the optimal dose to test in future patients.

minocycline is a widely used antibiotic and is approved by the food and drug administration (fda) for treatment of infections and acne. however, doctors do not know whether minocycline will work in stroke patients. its use in stroke patients is experimental. there is a lot of information from experimental stroke studies in animals that minocycline lessens the damage from a stroke and the animals recover better. since minocycline is generally a very safe drug in humans and does not have a lot of side effects, investigators at georgia health sciences university (formerly the medical college of georgia) believe that it might be a safe and effective drug to improve the outcome in patients with stroke.

Eligibility criteria:
inclusion criteria: * over 18 years of age * acute onset focal neurologic deficit consistent with acute ischemic stroke, or computed tomographic scan consistent with acute cerebral ischemia * onset of symptoms less than 6 hours * measurable neurologic deficit (national institutes of health \[nih\] stroke scale \>/= 1) exclusion criteria: * allergy to tetracycline antibiotics * women of child-bearing potential * known hepatic and/or renal insufficiency * thrombocytopenia * history of intolerance to minocycline * dizziness at the time of stroke or in the past month (by self-report) * aphasia likely to interfere with patients ability to report adverse effects * previous functional disability * stuporous or comatose * presence of another serious illness likely to confound the study * unlikely to be available for 90 day follow-up * severe stroke (national institutes of health \[nih\] stroke scale \>22) * undergoing an interventional neuro-radiological intervention in first 12 hour

Keywords: stroke ischemic neuroprotection minocycline tissue plasminogen activator (tpa) biomarkers pharmacokinetics antiapoptotic anti-inflammatory treatment matrix metalloproteinase-9 (mmp-9) thrombolysis minocycline to improve neurologic outcome in stroke (minos) cerebrovascular stroke cerebrovascular accident cerebral stroke cerebrovascular accident (cva)
impact of the continuous measurement of blood glucose on insulin pump on child quality of life with type 1 diabetes

Conditions: Type1diabetes

Summary: the implementation of a sensor of glycemia enlite coupled with an insulin pump (medtronic minimed 640g) is a therapeutic option that hospital of mulhouse can propose to the children affected by type 1 diabetes. the glycemic rate detected by the sensor of continuous measure of the glycemia is visible in real time on the pump and then the rate can be normalized. the study will evaluate the impact of the continuous measurement of blood glucose on insulin pump on child quality of life with type 1 diabetes aged 2 to 13 years old.

the french high health authority recommends, for patient with type1 diabetes, a supervision of at least 4 tests a day in pre and post prandial with additional controls in circumstances of meal or of unusual physical activities. du to age, this control need supervision of an adult, in each place of children life (school, nursery, out-of-school center ...), according to their autonomy. during several years, all the actors of educational care tried to improve the welcome of the children affected by handicap or by chronic disease. since 10 years, the team of pediatric diabetology of mulhouse hospital has developed a partnership with the department of education by setting up every year in september of a training courses for voluntary teachers and all staff nursery. these sessions are consisted of a formal time bringing knowledge on the disease, followed by exchanges and finally a practical time around manipulation of the readers of glycemia and pumps. alerts can be scheduled to warm an increase or an important reduction of blood glucose. the study will evaluate the child quality of life, and also parents and staffs in preschool, school or in out-of-school center felt too.

Eligibility criteria:
inclusion criteria: * enrollment between september 15 to november 15, 2016 * insulin-dependent type 1 diabetes with insulin pump * from 2 to 13 years old * schooled to the nursery or primary school, seeing frequently a day-nursery or in an out-of-school center * treated at the hospital of mulhouse, france exclusion criteria: * opposition to study participation * patients who don't need sensor of measure of the continuous glycemia

Keywords: type 1 diabetes children,school,childcare facilities,sensor
evaluation of the effectiveness of different toothbrushes in children

Conditions: Dental Plaque; Plaque, Dental; Oral Hygiene; Gingivitis; Periodontal Indexes

Summary: control groups will be formed in the 2-12 age group using standard manual toothbrushes, and the effectiveness of 360-degree bristle toothbrushes will be compared. study design: experimental study

in this randomized controlled, single-brushing study, children were assigned to a treatment sequence involving a 360-degree toothbrush and a control brush. subjects were randomly assigned to a treatment sequence involving a 360-degree toothbrush and a classical manual control toothbrush. parents brushed the teeth of their children aged 2-5 years, whereas children aged 6-12 years brushed their own teeth under the supervision of clinic staff, unaided by a mirror. clinical examination of each participant was carried out by the principal investigator. assessments were done pre- and post-brushing using the "silness and löe plaque index" (pi), gingival index (gi), and the simplified oral hygiene index (ohi-s). plaque indices were expressed as means and standard deviations (sd). within each toothbrush group, the follow-up scores were analyzed using a paired t-test. p \< 0.05 was considered statistically significant.

Eligibility criteria:
inclusion criteria: * healthy children aged 2-12. * children without systemic disease or developmental dental anomalies. * children not undergoing orthodontic treatment. * children with no decay on the labial surfaces of upper anterior incisors. * patients or their parents accepting participation in the treatment. exclusion criteria: * children with decay on the labial surfaces of upper anterior incisors. * children undergoing orthodontic treatment. * children who, along with their parents, do not agree to participate in the treatment will be excluded from the study.
primary prevention program

Conditions: Primary Prevention of Cardiovascular Disease

Summary: a systematic collection of retrospective and prospective data based on non-intervention patient observation, aimed to assess the risks, course and outcomes of a disease or a group of diseases: * the retrospective part: database of patients with cardiovascular risks; * the prospective part: observation of patients in the real medical practice

the research program will have two parts: stage1: identification of patients with moderate, high and very high cardiovascular risks, not having diseases of atherosclerotic genesis and requiring lipid-lowering drugs. stage 2: a prospective observation of patients receiving primary medical prophylaxis of cvd with atorvastatin

Eligibility criteria:
inclusion criteria: men and women 40-65 years old with the presence of: * moderate cardiovascular risk (\<5% but ≥1% on a score scale) and cholesterol level ldl ≥3.0 mmol / l, in which the target is not reached during the improvement of lifestyle level of cholesterol-ldl, and the attending physician considers appropriate the appointment lipid-lowering drugs (statins), or * high cardiovascular risk (≥5% but \<10% on a score scale) and cholesterol level ldl ≥ 2.5 mmol / l, or * very high cardiovascular risk (≥10% on the score scale) and cholesterol-ldl ≥1.8mmol / l, or * atherosclerotic stenosis of the brachiocephalic arteries\> 50% in the absence cerebrovascular diseases and the level of cholesterol-ldl ≥1.8 mmol / l, which do not have contraindications to taking statins and not taking drugs of this group in currently. exclusion criteria: * the presence of the following clinically significant events in anamnesis: myocardial infarction, stroke, myocardial infarction * the presence of the following diseases at the time of statin administration: ischemic heart disease; heart failure; atherosclerotic disease of peripheral arteries; atherosclerotic stenosis of the brachiocephalic arteries in the presence of cerebrovascular disease; chronic renal failure with creatinine clearance \<30 ml / min; liver disease with an increase in ast and alt levels of more than 3 times, compared to the upper limit of normal; history of muscular or neuromuscular diseases, with elevated cpk; alcoholism, oncological, mental and other severe concomitant diseases; intolerance to statins in anamnesis; use of other lipid-modifying agents.

Keywords: primary prevention cardiovascular risk hyperlipidaemia adherence
impact of chlordecone on active chronic hepatitis

Conditions: Fibrosis, Liver

Summary: chlordecone is known to induce liver damage in rat and mice but no data exists in human being. however chlordecone was used until 1993 in french west indies for banana fields, it is important to test what damage can be induced now, for patients exposed. we should consider chlordecone as a potential cofactor of liver fibrosis. so we have chosen to compare two populations of chronic hepatitis b, c or alcoholic, with cirrhosis or without fibrosis due to active hepatitis, who had been exposed to chlordecone.

actually, there is no data concerning the impact of chlordecone on the evolution of fibrosis to cirrhosis in chronic hepatitis whereas many studies have been reported liver damage in mice. the goal of this study is to know if co-exposition to chlordecone can induce evolution to cirrhosis in chronic hepatitis due to alcohol or viral hepatitis. at first, we will assess a group of patients with chronic hepatitis b, c or due to alcohol without fibrosis. and they will be compared to patients with cirrhosis exposed to chlordecone too. patients will be included in 2 hospital centers. all these patients should have an active liver disease. the activity will be defined by histology or elevated transaminases (\>2n), fibrosis will be defined by histology or an association of fibroscan and biological markers. exposition to chlordecone will be evaluated by a blood chlordecone measure for every patient.

Eligibility criteria:
inclusion criteria: * age above 18 years * active chronic hepatitis b or c or alcoholic * patient without previous antiviral therapy, activity confirmed by histology or elevated transaminases * alcohol consumption more than 20g/d for women and 30g/d for men responsible of chronic alcoholic disease * seronegative hiv status, inform consent signed, health insurance exclusion criteria: * inactive chronic hepatitis * other chronic hepatitis as auto-immune hepatitis, hemochromatosis, wilson disease, acute hepatitis due to medication, transplantation, antiviral or imunosupressive treatment, psychiatric disease * co-infection with hiv, hbv or hcv * pregnancy

Keywords: chlordecone fibrosis cirrhosis chronic hepatitis b, c alcohol viral hepatitis transaminases fibroscan
minimum alveolar concentrations of sevoflurane for maintaining bispectral index below 50 in morbidly obese patients

Conditions: Anesthesia

Summary: the target of this study is to assess the minimum alveolar concentration of sevoflurane to maintain thebispectral index below 50.the minimum alveolar concentration (mac) for maintaining bispectral index below 50 (macbis50) of sevoflurane has been reported previously in adult with body mass index ( bmi) \ 40). the first aim of our study is to assess the macbis50 of sevoflurane in morbidly obese patients bmi 40 - 70 using the continuous reassessment method (crm) in 80 % of patients.

after ethical committee approval and written informed consent, 30 morbidly obese adult patients , bmi 40- 70kg/m², asa physical status 1 and 2 , aged 18-49 yr, , undergoing elective bariatric surgery under general anesthesia using sevoflurane, were included in this study. monitoring consisted of noninvasive blood pressure, electrocardiogram (ecg) , pulse oximetry, and bis. all subjects received a standard dose of 2 mcg/kg fentanyl approximately 20 min before induction of general anesthesia. a standard bis® monitor strip was applied before fentanyl administration and induction of general anesthesia. induction was performed in all patients with 2m/kg propofol, 0.2 mg/kg cisatracuruim, followed by direct laryngoscopy and tracheal intubation. therefore, when bis reached \> 65 , sevoflurane was started immediately at the predetermined dose. the endtidal sevoflurane concentration was adjusted with starting dose for the first cohort patients 1% and maintained for 10 min to ensure equilibration with the cerebral anesthetic partial pressure followed by a 1-min assessment of bis taken at 10-s intervals. briefly, a first dose is given to the first patient and the next doses are given according to the following rule: if the subject responds positively (bis\ 50), the dose is increased one step. the dose adjustment is 0.2% for sevoflurane. the crm is used to calculate the dose adjustment for every cohort with the number of patients for every cohort .

Eligibility criteria:
inclusion criteria: * morbidly obese patient * bmi 40-70 * age : 20-40 year exclusion criteria: * age\ 40 * bmi \ 70 * comorbidity
covid-19 & psychiatry: a retrospective chart review

Conditions: COVID-19

Summary: a retrospective chart review study to determine the effects of psychotropic medications and prior psychiatric diagnoses on covid-19 patients' disease progression, and severity.

the goal of this study would be to study the association between use of psychotropic medications and prior psychiatric diagnoses on covid-19 patients' disease progression and severity.

Eligibility criteria:
inclusion criteria: - individuals with a positive covid-19 test between march 15 2020 to november 30 2021 at northwestern medicine hospitals. exclusion criteria: -
baclofen for rumination

Conditions: Rumination; Supra-gastric Belching

Summary: patients with a clinical suspicion of rumination syndrome and/or supra-gastric belching are randomized into baclofen or placebo for 2 weeks (10mg, tid). thereafter, they undergo a high resolution impedance manometry measurement, were they receive a solid meal, and recordings continue for another hour. thereafter, they will receive the alternative treatment, after which they will undergo a second high resolution impedance manometry measurement. patients are asked to fill out questionnaires during the entire study period.


Eligibility criteria:
inclusion criteria: * clinical suspicion of rumination syndrome and/or supra-gastric belching. * sexually active women of child bearing potential participating in the study must use a medically acceptable form of contraception. medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. * 18 to 75 years old. * subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed. exclusion criteria: * systemic diseases, known to affect esophageal motility. * surgery in thorax or in the upper part of the abdomen. * treatment with baclofen prior to the start of the study. * significant neurological, respiratory, hepatic, renal, haematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator. * pregnancy or breast feeding. * history of poor compliance. history of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent. (well-controlled depression is allowed). * history of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.
rehabilitation needs for hematologic cancer candidate for hematopoietic stem cell transplantation or car t-cell therapy

Conditions: Stem Cell Transplantation; Immunotherapy; CAR T-Cell Therapy

Summary: hematopoietic stem cell transplantation (hsct) and car t-cell therapy are effective treatments for blood cancers, extending patients lives. however, these treatments can cause side effects like muscle weakness and fatigue. recent findings suggest these issues can significantly affect patient quality of life during car t-cell therapy. patients undergoing hsct and car t-cell therapy often face frequent infections and strong immune responses, requiring long periods of rest. this worsens their physical condition and impacts their quality of life, muscle strength, and fatigue levels. minimizing these side effects is crucial to improve the well-being of patients undergoing these advanced treatments. this study aims to assess the physical abilities (main goal) of patients preparing for hsct or car t-cell therapy. it also aims to examine their quality of life and describe the symptoms and complications they may experience. the results will help identify rehabilitation needs for these patients.

this is a prospective observational study following strobe guidelines for observational studies in epidemiology. the study will take place at the azienda usl-irccs di reggio emilia, northern italy. participants will include adults with blood cancer scheduled for hsct or car t-cell therapy. they must be able to understand and speak italian and make an informed decision to participate in the study. patients will be identified at the hematology unit of azienda usl-irccs di reggio emilia. medical records will be reviewed to confirm eligibility. eligible patients will receive detailed information about the study and can decide to participate by signing a consent form. the study will last 24 months, with an 8-month enrollment period and an 8-month follow-up. approximately 20 participants will be enrolled based on the number of patients who received hsct and car t-cell therapy in 2023. data on participants sociodemographic and clinical characteristics will be collected at the start of the study. complications and hospitalizations will be monitored after treatments to understand their impact on patients health. this study aims to provide valuable insights into the rehabilitation needs of patients undergoing hsct and car t-cell therapy.

Eligibility criteria:
inclusion criteria: * patients with hematologic cancer scheduled to undergo hsct or car t-cell therapy; * age ≥18 years * able to provide informed consent to participate in the study * able to understand and participate in the study * able to understand and communicate in the italian language exclusion criteria: • patients who are unable to perform physical tests or have contraindications to movement

Keywords: functional status quality of life needs assesment physical conditioning, human hematologic neoplasms
3-week study of asenapine, olanzapine and placebo for treatment of bipolar mania (p07009)

Conditions: Bipolar Disorder

Summary: bipolar disorder is characterized by mood swings that range from high (manic) to low (depressed) states. sometimes, symptoms of both depression and mania are present (mixed episodes). asenapine is an investigational medication for the treatment of manic or mixed episodes of bipolar disorder. this is a 3-week study that will test the safety and efficacy of this medication. participants will receive either asenapine, olanzapine (a medication that is already approved for the treatment of bipolar mania), or placebo (no active medication). participants will be required to stay in the hospital for at least the first seven days of treatment. participants who complete the 3 week study may be eligible to continue in extension studies for an additional 9 (study a7501006) to 49 (study a7501007) weeks.


Eligibility criteria:
inclusion criteria: * have a diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv) diagnosis of bipolar i disorder, current episode manic or mixed. exclusion criteria: * participants with unstable medical conditions or clinically significant laboratory abnormalities or participants who are rapid cyclers (i.e., have had 4 or more (including current) mood episodes in the past 12 months); have any other psychiatric disorder other than bipolar i disorder as a primary diagnosis.